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E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Draft Guidance for Industry September 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1791


Docket Number:
FDA-2020-D-1791
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential—Questions and Answers

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